: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase 1a and Phase 1b. Phase 1a has 2 stages, skin/subcutaneous lesions stage, deep (visceral) lesions stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
JCXH-211 administered once every 28 days or 14days
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, China
Dose limiting toxicity
Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation.
Time frame: Within 28 days or 14days after the first dose
Incidence of adverse events (Safety and Tolerability)
Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs).
Time frame: From consent to 28 days after the last dose of study drug
Duration of response (DoR)
Duration of response is defined as the time from the first assessment of tumor as CR or PR to the first assessment as progressive disease or death from any cause.
Time frame: 6 months after the last patient is enrolled.
Disease control rate (DCR)
Disease control rate is defined as the proportion of patients with CR or PR or stable disease (SD) with the DoR ≥ 12weeks observed from Day 1 to disease progression.
Time frame: 6 months after the last patient is enrolled.
Progression-free survival (PFS)
Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier.
Time frame: 6 months after the last patient is enrolled.
Overall survival (OS)
Overall survival is defined as the time from Day 1 until death due to any cause.
Time frame: 6 months after the last patient is enrolled.
Objective response rate (ORR)
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Objective response rate is defined as the proportion of patients that achieve a complete response (CR) or partial response (PR) during the study participation.
Time frame: 6 months after the last patient is enrolled.
Clinical benefit rate (CBR)
Clinical benefit rate is defined as the proportion of patients with the best response of CR, PR, or SD (duration ≥ 24 weeks) throughout the study from Day 1 of treatment with the study drug to disease progression.
Time frame: 6 months after the last patient is enrolled.